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NCT ID: NCT05138094 Recruiting - Neoplasm Metastasis Clinical Trials

LIVACOR Trial: Minimally Invasive LIVer And Simultaneous COlorectal Resection

LIVACOR
Start date: August 6, 2021
Phase: N/A
Study type: Interventional

The LIVACOR - Trial is a European wide, randomized controlled, open-label, multicenter trial. Patients with synchronous colorectal liver metastases (CRLMs) and primary colorectal tumor are considered eligible and will be randomized between minimally invasive (MI) combined or staged colorectal resection (all colectomies, including high anterior resection) and liver resection of up to three segments.

NCT ID: NCT05137197 Recruiting - Clinical trials for Major Depressive Disorder

Confirm the Effectiveness of Predictix Genetics Antidepressant -Guided Treatment in Adults With MDD

Start date: October 4, 2021
Phase: N/A
Study type: Interventional

A randomized, controlled, prospective, multicenter, patient and rater blinded study with 2 arms: Treatment as Usual (TAU) and Predictix Guided Treatment (PGT). The study will compare the rate of treatment response and remission among both groups; TAU vs PGT.

NCT ID: NCT05133024 Recruiting - Postoperative Ileus Clinical Trials

Use of Beetroot Juice to Protect Against Postoperative Ileus Following Colorectal Surgery: BEET IT Study

BEET IT
Start date: March 31, 2021
Phase: Phase 2
Study type: Interventional

The goal of the BEET IT study is to examine if preoperative intake of beetroot juice can ameliorate gastrointestinal (GI) recovery after colorectal surgery and thereby help to reduce the duration of postoperative ileus (POI) and prevent prolonged POI. Adult patients undergoing laparoscopic colorectal surgery are randomized 1:1 to consume either concentrated beetroot juice (active intervention) or nitrate-depleted concentrated beetroot juice (placebo) during the week before their surgery. Blood, tissue and/or fecal samples are collected at specific time points pre- and/or postoperatively to study markers related to inflammation, oxidative stress and GI function. Patients are followed from the week before surgery (start of the intervention) until 3 months post-surgery. The study takes place at 5 hospitals in Flanders, Belgium.

NCT ID: NCT05132582 Recruiting - Clinical trials for HER2 Positive Breast Cancer

A Study of Tucatinib or Placebo With Trastuzumab and Pertuzumab for Metastatic HER2+ Breast Cancer

HER2CLIMB-05
Start date: March 7, 2022
Phase: Phase 3
Study type: Interventional

This study is being done to see if tucatinib works better than placebo when given with other drugs to treat participants with HER2-positive breast cancer. A placebo is a pill that looks the same as tucatinib but has no medicine in it. This study will also test what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease. Participants will have cancer that has spread in the body near where it started (locally advanced) and cannot be removed (unresectable) or has spread through the body (metastatic). In this study, all participants will get either tucatinib or placebo. Participants will be assigned randomly to a group. This is a blinded study, so patients and their doctors will not know which group a participant is in. All participants will also get trastuzumab and pertuzumab. These are 2 drugs used to treat this type of cancer.

NCT ID: NCT05126030 Recruiting - Clinical trials for Tricuspid Regurgitation

TRiCares Topaz Transfemoral Tricuspid Heart Valve Replacement System First In Human Trial

TRICURE
Start date: July 15, 2022
Phase: N/A
Study type: Interventional

The objective of this first in human study is to gain early clinical insight into the safety profile and performance of the Topaz transcatheter tricuspid valve replacement (TTVR) system intended for transfemoral access to deliver a self-expanding bioprosthetic valve within the tricuspid valve.

NCT ID: NCT05123703 Recruiting - Clinical trials for Relapsing-Remitting Multiple Sclerosis

A Study To Evaluate Safety And Efficacy Of Ocrelizumab In Comparison With Fingolimod In Children And Adolescents With Relapsing-Remitting Multiple Sclerosis

Operetta 2
Start date: February 4, 2022
Phase: Phase 3
Study type: Interventional

This double-blind, double-dummy study will evaluate the safety and efficacy of ocrelizumab compared with fingolimod in children and adolescents with relapsing-remitting multiple sclerosis aged between 10 and < 18 years over a duration of at least 96 weeks.

NCT ID: NCT05123482 Recruiting - Breast Cancer Clinical Trials

A Phase I/IIa Study of AZD8205 Given Alone or in Combination With Anticancer Drugs, in Participants With Advanced or Metastatic Solid Malignancies

Start date: October 18, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This research study is studying a new compound, AZD8205, as a possible treatment for advanced or metastatic solid tumours alone or in combination with anti-cancer agents

NCT ID: NCT05122039 Recruiting - Psoriasis Clinical Trials

ProspectIve Cohort psoriASiS fOllow-up (PICASSO)

PICASSO
Start date: October 20, 2021
Phase:
Study type: Observational [Patient Registry]

The main purpose of the PICASSO-project is to facilitate future psoriasis-research in dermatology. This register biobank will enable us to perform research in the field of metabolomics, mRNA-expression, cardiovascular impact and the microbiome. The final aims are patient stratification, better insight in disease-evolution and improved understanding of markers that predispose to severe disease.

NCT ID: NCT05120752 Recruiting - Clinical trials for Irritable Bowel Syndrome

Efficacy of a Low FODMAP Diet in the Absence of Lactose Malabsorption in Moderate to Severe ROME IV IBS.

Start date: November 2, 2021
Phase: Phase 3
Study type: Interventional

Irritable bowel syndrome (IBS) is a frequently encountered disorder. According to the Rome IV criteria, it is characterized by abdominal pain associated with a change in stool frequency or con-sistency, or with symptomatic improvement by defecation (Mearin 2016). Associated symptoms, such as bloating and flatulence, are frequently reported. The underlying pathophysiology remains obscure, although several pathways have been proposed. Low-grade immune activation, visceral hypersensitivity, alteration in gut microbiome have all been reported (Mearin 2016). As diet exerts an impact on all these pathophysiological mechanisms, the role of dietary intervention receives spe-cial attention, with special interest in the role played by so-called fermentable oligo-, di-, monosac-charides and polyols (FODMAPs). Multiple studies indicated the beneficial effects of the low FODMAP diet in at least part of the patients (Halmos 2014, Eswaran 2016, Staudacher 2017). As a disaccharide, lactose is part of the FODMAPs. Lactose intolerance (LI) results from lactose malabsorption (LM) secondary to insufficient hydrolysis of the disaccharide lactose into galactose and glucose (Misselwitz 2019). The undigested lactose will eventually reach the colon, resulting in fermentation from colonic bacteria with production of different compounds such as short chain fat-ty acids, carbon dioxide, H2 and methane (Catanzaro 2021). These compounds have an osmotic effect and can stimulate colonic contractions. In patients suffering from LI, these pathophysiologi-cal mechanisms generate symptoms such as abdominal pain and cramps, flatulence, diarrhea, in-creased bowel sounds, among others, similar to the mechanisms by which FODMAPs induce symp-toms of IBS. As dairy products are highly present in our Western diet, LI will often be considered in patients presenting with such symptoms and they will be referred for further testing. When LM is diagnosed, a lactose-free diet (LFD) will be advocated to alleviate symptoms. While the earlier-mentioned studies investigated symptomatic improvement by the low FODMAP diet, it remains uncertain whether this restrictive diet remains beneficial in patients without evidence of LM. In a recent study the low FODMAP diet and LFD provided comparable improvement in symptom severity (Krieger-Grübel 2020). This study aims to: - Assess the improvement in IBS symptoms and quality of life (QOL) by a low FODMAP di-et when lactose malabsorption has been previously excluded; - Compare the improvement in IBS symptoms and QOL obtained by a low FODMAP diet to a lactose free diet (data from the PreVaIL study).

NCT ID: NCT05118789 Recruiting - Clinical trials for Metastatic Solid Tumor

A Study of NVL-520 in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)

Start date: January 4, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

Phase 1/2, dose escalation and expansion study designed to evaluate the safety and tolerability of NVL-520, determine the recommended phase 2 dose (RP2D), and evaluate the antitumor activity in patients with advanced ROS1-positive (ROS1+) NSCLC and other advanced ROS1-positive solid tumors. Phase 1 will determine the RP2D and, if applicable, the maximum tolerated dose (MTD) of NVL-520 in patients with advanced ROS1-positive solid tumors. Phase 2 will determine the objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) of NVL-520 at the RP2D. Secondary objectives will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS), and clinical benefit rate (CBR) of NVL-520 in patients with advanced ROS1-positive NSCLC and other solid tumors.